Akorn, Inc. Announces Positive Phase III Pivotal Trial Results for AktenBUFFALO GROVE, Ill.--(BUSINESS WIRE)--Jan 23, 2007 - Akorn, Inc. (AMEX: AKN) today announced the positive results of a Phase III pivotal trial for Akten(R). The clinical trial was a randomized, placebo controlled, multi-centered, 4-arm trial in 209 subjects. The primary efficacy end point for achieving ocular anesthesia (p less than 0.001) and the secondary end point for duration of anesthesia (p less than 0.001) were both statistically significant for all three study drug dosages.
Akten(R) is an Investigational New Drug (IND) product indicated for ocular anesthesia. Akorn filed a patent for Akten(R) in October 2006. The protocol design was discussed with the U.S. FDA prior to filing the IND in 2006. Akorn now intends to file a 505(b)(2) New Drug Application (NDA) in the second quarter of 2007. Akten(R) is intended to be used in various surgical and office-based ophthalmic procedures with an estimated market size of six million annual procedures.
Abu Alam, PhD, Akorn's Senior Vice President of New Business Development and Clinical Study Director stated, "This is a very important milestone in our Company's history. Akten(R) is expected to be the first ethical drug product internally developed by Akorn. Akten(R) is a unit dose, preservative free drug product and is manufactured at our Somerset, NJ facility. Once approved, Akten(R) will be marketed directly by Akorn to ophthalmologists".
Arthur S. Przybyl, Akorn's President and Chief Executive Officer stated, "Akten(R) represents an important proprietary ophthalmic drug product opportunity for Akorn. These trial results will allow us to proceed with the NDA filing in the second quarter of 2007".
About Akorn, Inc.
Akorn, Inc., headquartered in Buffalo Grove, Illinois, develops, manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company's website at www.akorn.com.
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Arthur S. Przybyl
President and CEO
Posted: January 2007